Depuy Ireland UC - FDA 510(k) Cleared Devices
Recent clearances: Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement, INHANCE™ Reverse Shoulder System, VELYS™ Hip Navigation
48
Total
48
Cleared
0
Denied
FDA 510(k) Regulatory Record - Depuy Ireland UC Orthopedic ✕
47 devices
Cleared
May 15, 2026
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
Orthopedic
87d
Cleared
Mar 11, 2026
INHANCE™ Reverse Shoulder System
Orthopedic
113d
Cleared
Nov 19, 2025
ATTUNE™ Total Knee System
Orthopedic
54d
Cleared
May 23, 2025
RECLAIM Monobloc Revision Femoral Stem
Orthopedic
28d
Cleared
Jan 22, 2025
EMPHASYS Acetabular System
Orthopedic
30d
Cleared
Dec 23, 2024
INHANCE INTACT™
Orthopedic
73d
Cleared
Nov 21, 2024
ATTUNE™ Revision Hinge Knee
Orthopedic
59d
Cleared
Oct 07, 2024
EMPHASYS Acetabular Shell with RapiTite HA
Orthopedic
83d
Cleared
Jul 11, 2024
ATTUNE™ Revision Knee System
Orthopedic
90d
Cleared
Jun 18, 2024
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and...
Orthopedic
99d
Cleared
Jun 05, 2024
VELYS Robotic-Assisted Solution
Orthopedic
132d
Cleared
Apr 04, 2024
PINNACLETM Constrained Acetabular Liners
Orthopedic
29d
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